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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRECICE STRYDE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
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PRECICE STRYDE SYSTEM; ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES Back to Search Results
Model Number PS10.0-80SJ280
Medical Device Problem Code Break (1069)
Health Effect - Clinical Code Failure of Implant (1924)
Date of Event 10/11/2021
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
Device evaluation: visual inspection of the returned nail confirmed the reported failure.Due to the condition of the nail, functional testing was not applicable.Broken nails are a known issue and can happen when the implanted nail is subjected to undue stress owing to factors such as patient activities, fall, etc.The type of breakage observed can result due to excessive stress being applied by the patient during daily activities or a fall.Device records review: review of the device history record for the nail confirmed that it met all of the required quality inspections prior to release.If any additional information is provided, a supplemental report will be submitted.
 
Event or Problem Description
Information was received that a broken stryde nail was explanted.No patient adverse event was reported.
 
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Brand Name
PRECICE STRYDE SYSTEM
Common Device Name
ROD, FIXATION, INTRAMEDULLARY AND ACCESSORIES
MDR Report Key12745220
Report Number3006179046-2021-00490
Device Sequence Number11882056
Product Code HSB
UDI-Device Identifier00887517951618
UDI-Public887517951618
Combination Product (Y/N)N
Initial Reporter StateMD
Initial Reporter CountryUS
PMA/510(K) Number
K180503
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2020
Device Explanted Year2021
Serviced by Third Party (Y/N)N
Reporter Type Manufacturer
Report Source company representative,health
Initial Reporter Occupation Physician
Type of Report Initial
Report Date (Section B) 11/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Operator of Device Health Professional
Device Model NumberPS10.0-80SJ280
Device Lot Number9120232
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/12/2021
Was the Report Sent to FDA? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 10/11/2021
Initial Report FDA Received Date11/03/2021
Was Device Evaluated by Manufacturer? (Y/N) Yes
Date Device Manufactured12/02/2019
Is the Device Labeled for Single Use? (Y/N) Yes
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Usage of Device Initial
Patient Sequence Number1
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